エグゼクティブサマリー

法務の社内影響力の強化

製品開発に影響を及ぼすための法的戦略の活用

多機能コミュニケーションを通じた法規制戦略の導入

法規制当局との効果的関係

法規制当局を理解することが有利な関係を促進する

法規制当局との関係維持

法務マネジメントベンチマーク

効果的な法務構造と人材

法務の支出と活動の管理

図表

目次

Product Code: PH194

The rapidly fluctuating global compliance environment has placed demands on
life science companies to evolve their regulatory strategies. With this study,
regulatory affairs teams and strategic decision makers will be able to
effectively communicate compliance priorities to clinical and marketing
groups, maximize the team's influence on all aspects of product development
and solidify relationships with regulatory agencies. To facilitate these
objectives, the study includes detailed data showing communication processes
between regulatory affairs groups and internal and external teams, as well as
budgets and activities supported by these groups.

KEY QUESTIONS

ANSWERING CRITICAL QUESTIONS FOR OUR CLIENTS

The data and analysis contained in this report will help you answer many
questions as you make your regulatory affairs strategy decisions. Here are
some of the key questions answered in this benchmarking study:

KEY QUESTIONS ANSWERED IN THIS REPORT

What is the regulatory affairs team's goal?

What are regulatory affairs groups' roles in product development?

Why should companies promote communication between regulatory teams and
clinical and commercial groups?

Why is collaboration between centralized regulatory affairs groups and
local specialists important?

What is the ideal time for regulatory affairs teams to get involved during
product development?

How can companies best coordinate regulatory affairs team activities?

Why should companies have a dedicated regulatory affairs budget?

Which regulatory affairs subfunction requires the most funding?

What kinds of challenges should companies expect when working with
government agencies?

What can companies do to address regulatory agencies' questions and
concerns?

KEY FINDINGS

PHARMACEUTICAL REGULATORY AFFAIRS

Cutting Edge Information analysts synthesized the following principles from
the full breadth and depth of this project's research. The principles are
signposts to help you improve your company's regulatory affairs team's
strategies and practices. While these points are not inclusive of all elements
in this report, they emphasize its central and most critical concepts.

1. USE REGULATORY INTELLIGENCE TO ALIGN COMPANY POLICIES WITH CURRENT
REGULATIONS

2. IMPLEMENT REGULATORY STRATEGY WITH CROSS-FUNCTIONAL COMMUNICATION
THROUGHOUT PRODUCT DEVELOPMENT